Posted today on Seeking Alpha:
ANI Pharmaceuticals Submit Application for Relaunching Cortrophin Gel
ANI Pharmaceuticals Inc. (ANIP) announced that it has submitted a Prior Approval Supplement to the FDA. The supplement has been filed with the Endocrinology Division of the regulatory body. The application pertains to the re-commercialization of Purified Cortrophin® Gel (Repository Corticotropin Injection USP) (80 U/mL). The drug was initially approved by the FDA in 1954 and had over 54 indications on its approved label. Some of the most prominent conditions treated by the gel were ulcerative colitis, systemic lupus erythematosus, and multiple sclerosis.
ANI Pharmaceuticals has spent over $100 million for re-establishing and validating the commercial corticotropin active pharmaceutical ingredient (API) and Cortrophin® Gel drug product manufacturing processes. The company had acquired the NDA for the gel from Merck (NYSE:MRK) in 2016. ANI has attached a comprehensive characterization package with its PAS. The package provides in-depth information about the API as well as about Cortrophin Gel. It has been proved that the drug meets both the historical release specifications and modernized release specifications.
The US corticotropin market currently has only one product H.P. Acthar® Gel from Mallinckrodt (NYSE:MNK). Earlier, there were more than half a dozen approved and active corticotropin NDAs. However, all but ANI's Cortrophin® Gel and Cortrophin® Zinc were withdrawn and are not available in the markets. Dr. Mark Ginski, Vice President of Corticotropin Development for ANI said:
We are very pleased to have submitted this PAS on schedule and in hopes of bringing Cortrophin® Gel back to the market for both patients and physicians."
The company said that it has brought significant modernization to various processes.
ANI also stated that it plans to market the drug at a substantial discount to the current pricing of H.P. Acthar Gel. The company said that it also aims to reduce drug costs for the US government as nearly 60 percent of corticotropin spending is done by the government through its Medicaid and Medicare programs. The FDA now has a four-month period to provide a response to the application and to decide whether the submission is complete or not.
The PDUFA goal date for the FDA has been set on July 23, 2020. The company said that it anticipates the immediate launch of the drug depending upon the approval. The market for repository corticotropin injection 80 U/ml is pegged at $950 million. ANI Pharmaceuticals has a robust drug development pipeline with a focus on developing treatments for oncolytics (anti-cancers), hormones and steroids, extended-release products and narcotics.
ANI Pharmaceuticals also provided an update about the coming departure of its CEO Arthur S. Przybyl, who also serves as the company President on May 10, 2020. Mr. Przybyl said:
After 11 years as President and CEO of ANI, the Board and I have determined that the time is right to transition to new leadership as the Company prepares to launch Cortrophin® Gel and expand its portfolio of specialty pharmaceutical products."
The board is, currently, searching for new CEO and president.
This last statement seems like an afterthought. I believe we hit a nader on price as a consequence to Art's dismissal specifically, how low it can go is going to be dependent on the BOD and Art's delivery of Earnings (which I suspect he'll be doing as his final act as CEO).
-RG
AI
